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Tismesh System

by Ti-Mesh, Inc.

510(k) K923419

Active United States

510(k)

Valid until

No expiry

510(k) clearance is not time-limited

FDA recalls

None found

in data synced 6 Oct 2026

Documents

Trust

Unverified

Registry data, not yet checked by deviCERTS. Source FDA 510(k), synced 6 Oct 2026. What this means

Regulatory status

as of registry sync 6 Oct 2026

RegionAuthorizationNumberDateStatus
United StatesFDA 510(k)SESE Substantially Equivalent · Traditional NumberK923419 Date8 Apr 1993ClearedStatusActive

Recalls

0 recalls · FDA

No FDA recalls found in the data synced 6 Oct 2026.

Coverage

1 jurisdiction

United States of America
  • Active
  • Expiring
  • Withdrawn
  • Listed
  • Not covered

United States — FDA 510(k) Active

Specification

510(k)

510(k) Number
FDA Product Code
JEY
Device Class
Class II
Regulation
21 CFR Part 872.4760
Advisory Committee
Dental
FDA Decision
SESE Substantially Equivalent

Overview

AI-generated summary, 25 Sep 2026

Written by a language model from registry data. Not verified by deviCERTS or the manufacturer. The registry data above is the record.

The TISMESH SYSTEM is a titanium mesh device intended for use in dental bone augmentation and Guided Bone Regeneration (GBR) procedures. It is designed to maintain the bone graft space and provide structural support to facilitate stable new bone formation. The device is composed of pure titanium, combining high structural strength with excellent biocompatibility.

The TISMESH SYSTEM is supplied by Ti-Mesh, Inc. and is cleared under FDA 510(k) number K923419. It is intended for single use in surgical settings and should be stored in a dry, sterile environment. The device is classified under product code JEY and is regulated as a Class II medical device.

Other devices from Ti-Mesh, Inc.